What is valbenazine studying for tardive dyskinesia?

Valbenazine is being studied to see how it affects symptoms and quality of life in adults with tardive dyskinesia who remain symptomatic while on or after stopping a VMAT2 inhibitor. Researchers are evaluating its impact on involuntary movements and patient-reported outcomes. The study is sponsored by Neurocrine Biosciences.

Who may be eligible for this tardive dyskinesia clinical trial?

Adults 18 years or older diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder, who have mild or greater tardive dyskinesia symptoms for at least 3 months may be eligible. People with Parkinsonism or recent substance use disorder are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this tardive dyskinesia clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel costs to and from study visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID07105111

A Phase 4 Open-Label Study Evaluating Valbenazine for Adults with Tardive Dyskinesia Remaining Symptomatic on or After VMAT2 Inhibitor Treatment

Led by Neurocrine Biosciences · Updated on 2026-05-08

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of valbenazine in adults with tardive dyskinesia TD who continue to have symptoms while taking or after stopping a vesicular monoamine transporter 2 VMAT2 inhibitor. This Phase 4 open-label study focuses on both clinician- and patient-reported outcomes to better understand valbenazines impact on TD symptoms in participants with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. Participants will receive oral valbenazine capsules once daily for 24 weeks. The study monitors changes in involuntary movement using the Abnormal Involuntary Movement Scale AIMS and evaluates other measures related to disease severity and quality of life. This open-label treatment period allows all participants to receive the study drug without placebo comparison. During the study, participants will undergo assessments at baseline and Week 24 including movement evaluations, clinical global impression scores, and patient-reported impact and health-related quality of life scales. Researchers will track safety and tolerability throughout the 24-week treatment. Total participation time corresponds to the 24 weeks of daily valbenazine treatment and follow-up assessments.

CONDITIONS

Brief Title

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

18 years of age or older
Diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder at least 3 months before screening
Diagnosed with at least mild neuroleptic-induced tardive dyskinesia for at least 3 months before screening

You will not qualify if you...

Presence of Parkinsonism or abnormal involuntary movements more prominent than tardive dyskinesia
Diagnosis of moderate or severe substance use disorder within the last 6 months
History of long QT syndrome, cardiac arrhythmia, or severe liver impairment

Research Team

Neurocrine Medical Information Call Center

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